Objective: Determination of esomeprazole efficacy in treatment of early onset pre-eclampsia.
Design: Forty six pregnancy women that suffer to preeclampsia with a gestational age of 26 to 32 weeks are entered in this study. Patients are randomly assigned to two groups according to a random number table generated by the computer. Since this study can be effective in reducing side effects, this study is phase 3. Setting and conduct: This study is a prospective clinical trial, single blind and randomized control group (placebo) that will be performed in the Hospitals of Mashhad University of Medical Sciences onto pregnant women who suffer to preeclampsia with a gestational age of 26 to 32 weeks will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082333680N2
Registration date:2017-10-22, 1396/07/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of esomeprazole efficacy in treatment of early onset pre-eclampsia
Public title
The evaluation of esomeprazole efficacy in treatment of early onset pre-eclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Preeclampsia diagnosis; hypertensive pregnancy; gestational age between 26 to 32 weeks; single-crowned pregnancy; no need to terminate the pregnancy in the next 48 hours; absence of anomalies in the fetus; patient satisfaction for expected treatment;
Exclusion criteria: Eclampsia; uncontrolled blood pressure; pulmonary edema; cerebrovascular accidents; heart failure; HELLP syndrome; use of proton pump inhibitors; renal failure; uncertain tests for the evaluation of embryo's health
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences, International Office Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Postal code
9138813944
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.MUMS.fm.REC.1396.40
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O15.0
ICD-10 code description
Eclampsia in pregnancy
Primary outcomes
1
Description
Duration of admission to delivery
Timepoint
before intervention until delivery
Method of measurement
Pregnancy termination
Secondary outcomes
1
Description
Frequency of maternal and fetal complications in patients with preeclampsia
Timepoint
before intervention until delivery
Method of measurement
Questionnaire and checklist
2
Description
Biomarker level of tyrosine kinase and endoglycine
Timepoint
after Intervention
Method of measurement
Blood test
Intervention groups
1
Description
The intervention group received 12 mg Betamethasone in two doses every 24 hours plus prescribed 40 mg osmoparazole daily.
Category
Treatment - Drugs
2
Description
The control group received 12 mg Betamethasone in two doses every 24 hours plus prescribed 40 mg placebo daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyedeh Azam Pourhoseini
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences, International Office Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Shourvarzi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital. Taghi-Abad Square,
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
sheida20shoorvarzi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mirzaeian
Position
Assistant professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Square Taghi-Abad.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
mirzaeians@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
Master
Other areas of specialty/work
Street address
Woman Health Research Center, Imam Reza Hospital, Taghiabad Square.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3853 8659
Fax
Email
golhasanif1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)